Estimation and Validation of Residual Solvent by GC Head Space Mass Chromatography of Colchicine USP
The present paper deals with the estimation and validation of residual solvent by GC head space mass chromatography of the drug Colchicine USP. The various parameters were evaluated and the data were presented in the present communications which establish the estimation and validation of the drug colchicines USP.
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The objective of validation of an analytical procedure is to demonstrate that it is suitable for the analysis of Colchicine for the determination of residual solvents/ Organic Volatile Impurities. The protocol is limited to validate the analytical procedure of colchicine for Organic Volatile Impurities only. The scope of this method validation protocol is to establish through documented evidence a high degree of assurance that an analytical method for organic volatile impurities will consistently yield results that accurately reflect the quality characteristics of the drug substance (Colchicine) tested.
The whole 17 pages article is available for download here.